MAGENTA (Managed Activity Graded Exercise iN Teenagers and pre-Adolescents) - Esther Crawley

One of the biggest problems with Esther Crawleys work is that she never really says what her 'hypothesis' is. She just appears to think that her treatment works (most of the time), the kids are all happy and that's it.

eta:

with reference to my last comment:
the real reason is it's what they do at her clinic
"
When can I increase my activity levels?
When you have managed 2 weeks of the same activity daily, you can start to increase by 10% a week."
http://www.ruh.nhs.uk/patients/serv...tric_cfs_me/documents/CFSEnergyManagement.pdf

eta2: also don't forget Crawley was a key advisor for the 2007 NICE guidelines; I don't what the 'rules' re increasing activity %s for GET before that were(?).

 

The authors are introducing a rule on how to interpret accelerometer data that can only increase, never decrease, apparent activity levels.

It's possible that their assumption is valid. One would have to check how they justify this.

It's also possible that "periods of sixty minutes or more with zero readings" might just be periods where the patient is sleeping during the day due to exhaustion. In my experience, periods where I attempted to be more active and walk every day or most days, resulted in much more daytime sleep. If the device is not highly sensitive or the patient simply doesn't move, then these daytime naps could be erroneously counted as no wear time. The kind of exhaustion that makes me sleep or nap during the day tends to be so profound that I don't even moving a limb or turn around in bed.

Does this indicate that a patient could have received treatment for up to 3 weeks before the first measurement of activity levels are made? Both treatment arms are described as having an initial activity reduction component. If the patient reduces their activity as told, and only then the first measurement of activity levels is performed, it could lead to the illusion of improvement.

This could easily happen if the patient, during the first contact with the service, receives both the accelerometer and the advice to reduce activity levels.

Such subgrouping could also give an unscrupulous reeseacher more opportunities for spin and p-hacking. For example it's possible that light activity increases at 3 and 6 months, but that moderate and vigorous activity decrease. If the researcher only reported that light activity levels increased it would be misleading. What is wrong with just reporting accelerometer counts?

I recall reading that people tend to temporarily modify their activity levels when they know that it's being recorded with accelerometers. So any measurements need to take this effect into account and be performed for long enough periods for this to not be a significant factor. Whether one week is enough needs to be checked.

Edited for clarity.

 

Oh I missed the part where accelerometer outcomes were quietly dropped.

Hopefully someone will get the data with FOI.

 

@MEMarge The criticisms by an exercise physiologist is certainly interesting - it shows that the GET used is really just a psychological therapy as it is not designed properly to improve fitness or seemingly even make sense to an exercise physiologist in this case.

 

I might have missed this in the exchanges. The trial registration lists the outcomes for both the feasibility study and the full trial. Is there a feasibility study protocol? Did they specify before doing the feasibility study what the full trial outcomes would be if it got extended, or did they just select them after gathering the data from the feasibility trial?

 

Nothing in the BMJ Open version of the trial protocol suggesting that they had pre-selected primary and secondary outcomes. They just listed all the measures they would take.

 

I love the comment from Dr Jason Fung!

 

And what exactly does "starting the trial" actually mean? Just getting on with the bureaucracy? Or actually beginning to run it operationally?

 

It would normally mean the start of recruitment for the trial, I think--just like a criminal trial formally begins on the date jury selection starts, at least in U.S.

 

Right--"substantial amendments" are officially only subject to a vote by a subcommittee of at least two.

 

My daughter was/is on the Activity Management arm, activities like bathroom visits, help getting dressed, eating are all high energy red activities. Once they achieved a certain amount of red per day then they were offered GET.
When completing our forms I actually wrote WC visit, putting on pj's etc, I doubt others did so not sure how results can be correct.
One of our first 'specialist' meetings involved asking to see daughter walk despite her being severe and in a wheelchair. Original protocol says no one in a wheelchair can be on the study!
I've requested results, have been assured they'll be sent via email.

 

Thanks a lot for posting.
We don't often get a chance to hear from people who take part in these recent 'studies'.
If there is anything you want to 'get off your chest' but not keen on posting on a public forum there is always the members only area which is a bit more (although not totally) 'private'.

 

I am slightly confused. I thought the oremise was to compare effectiveness between activity management and GET.
Surely if on the Activity management arm GET should not have been introduced?